Background: Deciding to stop or continue anticoagulation for venous thromboembolism (VTE) after initial treatment is challenging as individual risks of recurrence and bleeding are heterogeneous.
Aims: To develop and externally validate a model for prediction of 5-year recurrence- and bleeding risk in patients with VTE who completed an initial anticoagulant treatment of ≥3 months; to illustrate how this model can be applied for estimating absolute benefits and harms of extended anticoagulation in individual patients with VTE.
Methods: Competing risk-adjusted models are derived for prediction of
1) recurrent VTE and
2) clinically relevant, non-major and major bleeding.
Predictors are selected using penalized regression with easily available parameters. The models are derived from combined individual patient data of the Bleeding Risk Study, Hokusai-VTE, PREFER-VTE, RE-MEDY and RE-SONATE. External validity (discrimination, goodness-of-fit) will be assessed using the Danish National Patient Registry, EINSTEIN-CHOICE, GARFIELD-VTE, MEGA study and Tromsø study. Absolute recurrence risk reduction and increase in bleeding risk with extended treatment will be estimated by combining the models with hazard ratios from trials and meta-analyses.
Results: First analyses in 15,283 patients (median age 59 years (IQR46-69); 41% female) indicate that age, sex, BMI, Asian race, PE, proximal versus distal DVT, surgery, trauma or immobilization preceding the index event, history of cancer, stroke, chronic inflammatory disease, history of bleeding, NSAID use, statin use, hemoglobin, platelet count and D-dimer during anticoagulation are predictive of VTE recurrence and/or bleeding. Internal validation showed good calibration (Figure 1). An individual patient example is shown in Figure 2. Final models and results of external validation will be presented.
Conclusions: We anticipate that the models can be applied to predict the effect of extended anticoagulation for individual patients with VTE, which can be used to support shared decision-making.
Acknowledgement: We are grateful to the many colleagues whom contributed to this project.
To cite this abstract in AMA style:de Winter MA, Dorresteijn JAN, Carrier M, Cohen AT, Hansen J-, Kaasjager HAH, Middeldorp S, Raskob GE, Sørensen HT, Visseren FLJ, Wells PS, Büller HR, Nijkeuter M. Individual Benefits and Harms of Extended Anticoagulation in Patients with Venous Thromboembolism: The VTE-PREDICT Model [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 1). https://abstracts.isth.org/abstract/individual-benefits-and-harms-of-extended-anticoagulation-in-patients-with-venous-thromboembolism-the-vte-predict-model/. Accessed September 24, 2021.
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